Study to Evaluate BIIB019, Daclizumab High Yield Process (DAC HYP), when administered by Pre-filled Syringe

• Conditions: Relapsing-remitting Multiple Sclerosis; MedDRA version: 16.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-023856-97-PL
• Lead Sponsor: Biogen Idec Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-26
• Last Update Posted: 25 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Main Inclusion Criteria
1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected
health information (PHI) in accordance with national and local subject privacy regulations.
2. Aged 18 to 65 years old, inclusive, at the time of informed consent.
3. Must have a confirmed diagnosis of RRMS according to McDonald criteria, and a previous cranial MRI demonstrating lesion(s) consistent with MS.
4. Must have a baseline EDSS between 0.0 and 5.0.
5. Must have had 1 or more clinical relapses within the previous 2 years.
Inclusion Criteria for 3-Year Treatment Extension
1. Must have been compliant with the 205MS302 protocol during the initial 24-week treatment period and the 20-week washout period.
2. Must resume DAC HYP treatment =12 weeks after completion of the washout period
Inclusion Criteria for the TP-DI Sub-Study
1. Compliance with the 205MS302 protocol during the initial 24-week treatment period and through Week 40 of the 20-week washout period.
2. Must agree to resume DAC HYP treatment =12 weeks after
completion of the washout period
3. Must have normal LFT results (total bilirubin =1.5 × ULN, ALT/AST = 2 × ULN, and prothrombin time/partial thromboplastin time =1.2 ×
ULN).
4. Must have estimated creatinine clearance >60 mL/min.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria
1. Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
2. History of malignancy.
3. History of severe allergic or anaphylactic reactions.
4. History of abnormal laboratory results that is indicative of any significant major disease that would preclude administration of DAC
HYP.
5. History of human immunodeficiency virus or other immunodeficient conditions.
6. MS relapse that has occurred within the 30 days prior to Day 1 AND/OR the subject has not stabilized from a previous relapse prior to
Day 1.
7. History of, or positive screening test for hepatitis C or hepatitis B infection.
8. Varicella or herpes zoster virus infection within 6 weeks before screening.
9. Exposure to varicella zoster virus within 21 days before screening.
10. Any of the following abnormal blood tests at screening:
• hemoglobin =9.0 g/dL, platelets =100 x 109/L ,lymphocytes =1.0 x 109/L, neutrophils =1.5 ? 109/L
• (ALT)/(ALT/SGPT), (AST)/ (AST/SGOT), or (GGT) =2 ×ULN)
• serum creatinine =ULN
Treatment History
Any previous treatment with daclizumab or other anti-CD25 monoclonal antibody, total lymphoid irradiation, cladribine, T-cell or T-cell receptor
vaccination or any therapeutic monoclonal antibody, except natalizumab.
Any live virus vaccine within the 4 weeks prior to Day 1.
12. Infections requiring hospitalization or IV antibiotics within the 8 weeks prior to Day 1.
13. Elective surgery performed within the 2 weeks prior to Day 1 or scheduled through the end of the study.
14. Treatment with another investigational drug or approved therapy for investigational use within the 6 months prior to Day 1.
15. Treatment with mitoxantrone, cyclophosphamide, fingolimod, or
natalizumab within 1 year prior to Day 1.
16. Treatment with any of the following medications or procedures within the 6 months prior to Day 1:
• cyclosporine
• azathioprine
• methotrexate
• mycophenolate mofetil
• IV immunoglobulin (IVIg)
• Plasmapheresis/ cytapheresis
17. Treatment with any of the following medications within the 30 days prior to Day 1:
• IV or oral corticosteroid treatment
• glatiramer acetate
18. For subjects currently taking valproic acid, carbamazepine,
lamotrigine, or phenytoin:
• Treatment with any of these agents = 6 months prior to study entry
• Treatment with 2 or more of these agents for more than 6 months prior to study entry are excluded unless they reduce to =1 agent prior to study entry.
• Dose escalations of one of these agents within the 6 months prior to study entry are excluded
Current treatment with isoniazid, propylthiouracil, or nimesulide at the time of study entry .
Exclusion Criteria for 3-Year Treatment Extension
1. Subjects who permanently discontinued DAC HYP treatment in Study 205MS302 for any reason prior to the 20 week washout period.
2. ALT/SGPT, (AST/SGOT), or GGT =2xULN within 7 days prior to reinitiation of DAC HYP.
Additional Exclusion Criteria for Specific TP-DI Sub-Study
Subject permanently discontinued DAC HYP treatment in Study 205MS302 for any reason prior to Week 40.
Subject is positive for NAbs at Week 36.
Subject is on a regimen of therapeutic anticoagulation.
Subject has narrow angle glaucoma.
Use of any drug or supplement that inhibits or induces CYP1A2,
CYP2C9, CYP2C19, CYP2D6, or CYP3A activity within 14 days or 5 halflives (whichever is longer) before the first dose of probe-drug cocktail.
Consumption of grapefruit or grapefruit-conta

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified